JJY · Class I · 21 CFR 862.1660

FDA Product Code JJY: Multi-analyte Controls, All Kinds (assayed)

Leading manufacturers include Bio-Rad, Medical Analysis Systems, Inc. and Cliniqa Corporation.

673
Total
673
Cleared
64d
Avg days
1976
Since
673 devices
337–360 of 673
Cleared Apr 11, 1995
DOCUMENT SERUM MULTIANALYTE CALIBRATION VERIFICATION TEST SET
K950469
Casco Standards
Chemistry · 67d
Cleared Mar 21, 1995
LIQUID ASSAYED TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3
K944525
Medical Analysis Systems, Inc.
Chemistry · 186d
Cleared Mar 13, 1995
PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATED
K942458
Randox Laboratories, Ltd.
Chemistry · 293d
Cleared Feb 22, 1995
RNA MEDICAL'S EQUIL PLUS WITH GLUCOSE CONTROL
K950399
Bionostics, Inc.
Chemistry · 21d
Cleared Feb 10, 1995
LIQUISPEX(TM) LIQUID B2M/CRP CONTROL LEVEL 1 AND 2
K946049
Clinical Controls, Inc.
Chemistry · 60d
Cleared Jan 17, 1995
QUANITITATE GBCC VERIFIER SET
K944454
Beckman Instruments, Inc.
Chemistry · 127d
Cleared Jan 17, 1995
QUANTITATE ELECTROLYTE VERIFIER SET (SERUM RANGE)
K944455
Beckman Instruments, Inc.
Chemistry · 127d
Cleared Dec 29, 1994
DYE CHECK STRIPS 545-630
K943729
Awareness Technology, Inc.
Chemistry · 149d
Cleared Dec 09, 1994
DOCUMENT(R) AMMONIA/ETHANOL AQUEOUS CONTROL
K945315
Casco Standards
Chemistry · 38d
Cleared Dec 02, 1994
QUANTITATE ELECTROLYTE VERIFIER SET (URINE RANGE)
K944452
Beckman Instruments, Inc.
Chemistry · 81d
Cleared Nov 15, 1994
PROCHEQ 1 & 2
K944059
Prisma Systems
Toxicology · 88d
Cleared Oct 31, 1994
HCG/TSH CONTROL- LEVEL 1/LEVEL 2/LEVEL 3
K935599
Clinical Controls, Inc.
Chemistry · 346d
Cleared Oct 04, 1994
MULTI ANALYTE LINEARITY SET
K936245
Teco Diagnostics
Chemistry · 278d
Cleared Sep 14, 1994
BILIRUBIN PLUS/PEDIATRIC CONTROLS
K943290
Medi-Tech, Inc.
Chemistry · 68d
Cleared Sep 14, 1994
BLOOD GADS, ELECTROLYTE, GLUCOSE, LATATE AND BUN QUALITY CONTROL PRODUCT
K943754
Bionostics, Inc.
Chemistry · 43d
Cleared Aug 18, 1994
TRAK LIQUID CEREBROSPINAL FLUID CONTROL LEVELS 1 & 2
K941328
Medical Analysis Systems, Inc.
Chemistry · 153d
Cleared Jul 28, 1994
SERUM VOLATILES CONTROL - LEVELS 1 AND 2
K941698
More Diagnostics
Chemistry · 113d
Cleared Jul 28, 1994
WHOLE BLOOD VOLATILES CONTROL, LEVELS 1 AND 2
K941876
More Diagnostics
Chemistry · 101d
Cleared Jul 20, 1994
ACS CARDIO-TROL CONTROL
K941115
Analytical Control Systems, Inc.
Chemistry · 135d
Cleared Jun 16, 1994
N/T PROTEIN CONTROL SY/L, M, AND H
K941912
Behring Diagnostics, Inc.
Immunology · 58d
Cleared Apr 04, 1994
TMC I, II
K930534
Ciba Corning Diagnostics Corp.
Chemistry · 426d
Cleared Mar 22, 1994
FERTILITY PLUS 1, 2, 3
K935219
Ciba Corning Diagnostics Corp.
Chemistry · 147d
Cleared Mar 11, 1994
ACS O DILVENT PROTEIN DILUTION MATRIX
K940397
Analytical Control Systems, Inc.
Chemistry · 43d
Cleared Dec 27, 1993
PARA 4 PLUS
K933844
Streck Laboratories, Inc.
Hematology · 143d